Prospective development studies for novel procedures: Call for ideas

Do you know of a surgical or interventional procedure in development that needs better evidence to support its use? Would you be interested in working with IDEAL in developing and carrying out a prospective development study?

The IDEAL recommendation for procedures in the Development stage (2a) is the prospective development study (PDS).  The Development stage is when a technique or device is still being modified iteratively as a result of lessons learned on a case by case basis in the first cohort of patients.  Traditionally, published research on procedures at this stage has been in the form of the retrospective case series, which is criticised for its significant selection bias and other flaws. The prospective development study reduces the risk of bias but also provides more complete information about the process of innovation which allows the  reader to understand how the technique evolved to its current state and how applicable it may be to other settings. There are few procedures that have been published as prospective development studies, but two recent examples include minimally invasive oesophagectomy[1], published by Jane Blazeby and colleagues in 2011, and focal ablation of prostate cancer[2], published by Mark Emberton and colleagues in 2012.

No specific formal outline of a PDS exists, but IDEAL recommends that it includes the following:

  • Registered study protocol
  • Clear description of patient selection criteria
  • Recording of proportion of eligible patients selected
  • Ethical consideration for reasonable precautions against harm
  • Clear description of procedure
  • Sequential reporting of ALL cases over time, showing outcome in each case
  • Description of changes to procedure and indication,showing their  timings on the sequential display of cases
  • (Where appropriate) Use of statistical process control (SPC) methods
  • Relevant outcomes described, including unexpected outcomes
  • Use of standardised outcome measures

What other features should be included in a prospective development study? In order to improve the quality of surgical evidence and propagate the use of prospective development studies, ultimately phasing retrospective case series out of the literature, IDEAL needs your input.  We would be interested in working with suitable partners who are developing surgical innovations at this early stage,  to develop and report your work in the way we describe, and in interviewing you afterwards to develop a qualitative analysis of the strengths and weaknesses of the IDEAL Recommendations for this type of study. If you would like to explore this possibility, please contact the IDEAL Collaboration.

To get in touch, you can leave a reply on this post below, use our contact form (scroll to bottom of page) or tweet/ direct-message @IDEALCollab on Twitter.

References

[1] Blazeby JM, Blencowe NS, Titcomb DR, Metcalfe C, Hollowood AD, Barham CP. Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy. Br J Surg. 2011 Apr;98(4):544-51. doi: 10.1002/bjs.7387. Epub 2011 Jan 18.

[2] Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.

One thought on “Prospective development studies for novel procedures: Call for ideas

  1. Assessment of Prostatic artery embolisation as an alternative to TURP/ open prostatectomy in the treatment of symptomatic lower urinary tract symptoms due to outflow obstruction secondary to benign prostatic hyperplasia.

    In Southampton Dr Nigel Hacking and I (both Consultant Interventional Radiologists), along with a Consultant Urologist colleague, Mr Jon Dyer, have been conducting a primary evaluation/ safety profile study on this new indication for what is an established interventional radiology technique. We are the first centre in the UK to perform this following promising results published from centres in Lisbon, Portugal and Brazil.

    We had preliminary funding to perform 20 cases which we have now completed with good initial results and a good safety profile (no major complications). We are now keen to procede with a larger multicentre study.

    Would this fit with the call for ideas for prospective development studies?

    Please let me know if this sounds suitable. I am happy to provide our study protocol early results etc as required.

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